UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of opioid-induced nausea and vomiting
Acronym	Feasibility study of opioid-induced nausea and vomiting
Scientific Title	Feasibility study of opioid-induced nausea and vomiting
Scientific Title:Acronym	Feasibility study of opioid-induced nausea and vomiting
Region	Japan

Condition
Condition	Opioid-induced nausea and vomiting (OINV)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore impacts of dexamethasone for improving general condition of cancer patients on OINV for planning a clinical trial of OINV.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete response rate at 72 hour after initiation of opioids
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dexamethasone
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or clinically confirmed malignant disease 2) Age >= 20 years 3) Planned regular doses of morphine, oxycodone, hydromorphone, codeine or tramadol >= 15mg/day MEDD 4) No prior opioid use within 21 days 5) No prior systemic steroid >5 mg PSL equivalent within 7 days 6) No nausea or vomiting within 7 days 7) No regular use of antiemetics, peristaltic enhancer or antipsychotics 8) Laboratory tests within 14 days meet criteria 9) Orally ingestible 10) Clear consciousness 11) Ability to fill out patient diary 12) Written informed consent
Key exclusion criteria	1) Brain metastasis with edema or meningeal carcinomatosis 2) Peritoneal dissemination, intestinal obstruction or intestinal stenosis with intestinal dilation 3) Constipation >= Grade 3 4) History of diabetes requiring medication 5) Administration of antineoplastic agents with high or moderate emetic risk within 21 days 6) Administration of antineoplastic agents with low emetic risk within 7 days 7) Abdominal surgery within 21 days 8) Infection requiring systemic treatment 9) Active peptic ulcer 10) History of HBV infection 11) Delirium within 1 year 12) History of steroid psychosis 13) Allergy to dexamethasone 14) Other conditions inappropriate for participating in the study
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Etsuko Aruga / Nobuhiko Seki
Organization	Teikyo University School of Medicine
Division name	Dpt. Palliative Medicine / Oncology
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	earuga@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Takagi
Organization	Teikyo University School of Medicine
Division name	Dpt. Palliative Medicine
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	ytakagi@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	帝京大学病院（東京都）、がん・感染症センター都立駒込病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	15
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 05 Day
Date of IRB	2017 Year 03 Month 14 Day
Anticipated trial start date	2017 Year 03 Month 26 Day
Last follow-up date	2019 Year 05 Month 15 Day
Date of closure to data entry	2019 Year 05 Month 15 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 15 Day
Last modified on	2019 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036014